China hikes registration fees for drugs, medical devices

 27-May-15, Reuters

China's drug regulator has steeply raised the fees required to register drugs and medical devices in the world's second-biggest pharmaceutical market, as a lack of resources and expertise hinders its ability to process a rising number of applications.

Image: Pharma Logic Solutions

The fee for registering a new locally-made drug will soar to 624,000 yuan ($100,637) compared with just 35,000 yuan in 2013, the China Food and Drug Administrator (CFDA) said in a statement late on Wednesday.

"Handling drug and medical device applications and going through the process of examination and approval requires high costs in terms of man power and physical resources. This cost should be borne by the applicants," the regulator said.

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